SPL v2
SPL
SPL Set ID eb7c418b-8bee-26a3-e053-2a95a90a4e96
Route
TOPICAL
Published
Effective Date 2022-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arctium Lappa Root (0.012 g) Polyacrylamide (crosslinked; 0.01-0.2 Mole Percent Bisacrylamide) (0.8 g) Laureth-7 (0.12 g) Peg/ppg-20/6 Dimethicone (1.372 g) Alcohol (0.08 mL) Glycerin (0.048 g) Cetearyl Ethylhexanoate (4 g) Limonene, (+)- (0.08398 g) Panthenol (0.1 g) Imidurea (0.9 g) Fd&c Yellow No. 5 (0.00024 g) Riboflavin (0.6 g) Phenoxyethanol (0.00004 g) Fragrance 13576 (0.00012 g) Water (0.0252 g) Cetostearyl Alcohol (123.55598 mL) Propylene Glycol (26 g) Mineral Oil (10.148 g) Ethylhexylglycerin (6 g) Methylchloroisothiazolinone (0.0028 g) Methylisothiazolinone (0.045 g) Hops (0.15 g) Tioxolone (0.002 g) Propylparaben (0.0012 g) Yeast, Unspecified (12.6 g) Niacinamide (0.3 g) C13-14 Isoparaffin (0.24 g) Methylparaben (0.023 g) Glyceryl Stearate Se (0.48 g) Triisopropanolamine (7 g) Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (0.004 g)
Inactive Ingredients
Edetate Disodium Anhydrous Sodium Sulfate Sodium Benzoate Magnesium Aluminum Silicate Potassium Sorbate Pyridoxine Hydrochloride Sodium Laureth Sulfate Magnesium Chloride Magnesium Nitrate Thiamine Hydrochloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-10-20 Until 2028-02-03


Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Section 50565-1

Section 50570-1

Section 51727-6

Section 51945-4

Section 55105-1

Section 55106-9


Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Section 50565-1 (50565-1)

Section 50570-1 (50570-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)